Self-Collected Pap Smear for Cervical Cancer Screening

(Pap Trial)

Recruiting at 2 trial locations

Overseen By Karen E Dixon, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cervical cancer, Positive Pap, Hysterectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to find out if a self-administered (by the patient) Papanicolaou (Pap) smear is as accurate as a traditional Pap smear administered by a healthcare provider.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Self-Collected Pap Smear for Cervical Cancer Screening?

The research indicates that the Pap smear, including self-collected versions, is effective in identifying abnormal cervical cells, such as atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL), which are important for early detection and management of potential cervical cancer. ^{1 2 3 4 5}

Is the self-collected Pap smear generally safe for humans?

The research articles do not provide specific safety data for self-collected Pap smears, but traditional Pap smears are widely used and considered safe for cervical cancer screening. ^{2 4 5 6 7}

How does the Self-Collected Pap Smear treatment differ from traditional cervical cancer screening methods?

The Self-Collected Pap Smear allows women to collect their own cervical cell samples at home, which can increase participation in cervical cancer screening by making it more convenient and less invasive compared to traditional methods where a healthcare provider collects the sample. ^{5 8 9 10 11}

Research Team

John B Waits, MD

Principal Investigator

PI

Eligibility Criteria

This trial is for women aged 21-65 in rural Alabama who are due for routine cervical cancer screening. It's not open to those with a history of cervical cancer, a positive Pap smear result, those who've had their uterus and cervix removed, or anyone in another cancer prevention study.

Inclusion Criteria

I am a woman aged 21-65 needing a routine cervical cancer screening.

Exclusion Criteria

Currently enrolled in any other cancer prevention study.

Positive Pap smear

I have had my uterus and cervix removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Self-Collection and Traditional Pap Smear

Participants will self-administer a Pap smear and also have a traditional Pap smear collected by a healthcare provider. Specimens will be blinded and sent for analysis.

1 day

1 visit (in-person)

Analysis and Notification

Specimens are analyzed for accuracy and participants are notified of the results.

2-4 weeks

Follow-up

Participants are monitored for any further necessary actions based on Pap smear results.

4 weeks

Treatment Details

Interventions

• Self-PAP
• Traditional Pap smear

Trial Overview The study is comparing the effectiveness of self-administered Pap smears (Self-PAP) versus traditional Pap smears done by healthcare providers to see if they're equally accurate for cervical cancer screening.

Participant Groups

Group I: Traditional Pap Experimental Treatment 1 Intervention

Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy.

Group II: Self-PAP Experimental Treatment 1 Intervention

Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy.

Self-PAP is already approved in United States, European Union for the following indications:

Approved in United States as Self-Collected Pap Test for:

• Cervical Cancer Screening

Approved in European Union as Self-Collected Pap Test for:

• Cervical Cancer Screening

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+

Cahaba Medical Care Foundation

Collaborator

Trials

1

Recruited

250+

Findings from Research

A repeat Pap smear using an ASCUS-positive threshold is more effective for detecting high-grade cervical lesions (CIN 2/3), identifying 83% of cases, compared to using an LSIL-positive threshold, which was ineffective.

The Hybrid Capture HPV DNA test showed similar sensitivity for detecting CIN 2/3 as a repeat Pap smear, but combining both tests did not significantly enhance detection rates, indicating that women with ASCUS or LSIL results should be referred for colposcopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triage of women with ASCUS and LSIL on Pap smear reports: management by repeat Pap smear, HPV DNA testing, or colposcopy? Ferris, DG., Wright, TC., Litaker, MS., et al.[2022]

The Bethesda Pap Smear system, revised in 1991, enhances the clarity and reproducibility of Pap smear reporting by requiring pathologists to provide not only readings but also clinical recommendations, thus improving patient management.

It categorizes cervical abnormalities into low-grade (LGSIL) and high-grade (HGSIL) lesions based on their biological potential, which helps in determining the appropriate follow-up and treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bethesda system and evaluation of abnormal pap smears. Nguyen, HN., Nordqvist, SR.[2019]

A web-based survey involving 53 cases of atypical squamous cells (ASC-H) revealed low consistency in diagnosis, with only 29.2% of brush-scraped and 26.2% of cotton swab-scraped cases being identified as ASC-H by participants.

The study identified distinct cytological features, such as three-dimensionality, coarse chromatin, and irregular nuclei, that can help differentiate between high-grade squamous intraepithelial lesions and benign cases, suggesting that online sharing of diagnostic information could improve consistency among pathologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World wide web-based cytological analysis of atypical squamous cells cannot exclude high-grade intraepithelial lesions. Washiya, K., Takamizu, R., Kumagai, Y., et al.[2022]

The management of atypical squamous cells of undetermined significance (ASCUS) in Pap smears is challenging because most women with this result are normal, yet a small percentage (5-11%) may have high-grade cervical lesions or cancer.

Atypical glandular cells of undetermined significance (AGUS) are less common but pose a higher risk for serious conditions like high-grade cervical intraepithelial neoplasia and cancer, leading to more straightforward management compared to ASCUS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of atypical squamous cells of undetermined significance and low-grade squamous intra-epithelial lesion by human papillomavirus testing. Cox, JT.[2022]

In a study of 447 patients, the correlation between cytologic results and histologic findings showed that as the grade of cervical lesions increased from ASCUS to HSIL, the likelihood of positive histology results also increased, with HSIL showing a 59.2% confirmation rate.

The findings suggest that cases diagnosed as ASCUS should undergo further colposcopic and histologic evaluation to ensure accurate diagnosis and management, as only 19.1% of ASCUS cases were histologically positive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) and histology. Rossetti, D., Gerli, S., Saab, JC., et al.[2022]

The study evaluated 101 cervical smears from women with uncertain PAP results, revealing that the CINtecPLUS test effectively identifies cervical lesions, with positive diagnoses in 26.3% of ASCUS, 54.2% of LSIL, and 87% of ASC-H cases.

Combining conventional cytology with the CINtecPLUS test can improve diagnostic accuracy for cervical abnormalities, potentially leading to better management strategies, especially for young women who may wish to avoid more invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Verification of doubtful PAP smear results of women included in the screening program in the Podlaskie province]. Błońska, E., Knapp, PA.[2022]

In a study of 52,339 women screened with Pap Tests, a significant correlation was found between high-grade squamous intraepithelial lesions (HSIL) and the detection of carcinoma in situ (CIS), with 40.7% of HSIL cases leading to CIS upon follow-up.

The findings suggest that while HSIL indicates a high likelihood of CIS and invasive carcinoma, a notable percentage of patients with CIS (about 33%) and invasive carcinoma (about 25%) had initial Pap results that were less severe than HSIL, highlighting the need for careful follow-up strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Pap Test terminology and age in the detection of carcinoma invasive and carcinoma in situ in medically underserved California women. Howell, LP., Tabnak, F., Tudury, AJ., et al.[2022]

In a study of 208 patients, self-collected vaginal samples showed varying sensitivity for HPV tests compared to physician-collected samples, indicating that the choice of test system can significantly impact screening results.

Self-collected Pap tests demonstrated a very high positive predictive value, suggesting they could be effective for cervical cancer screening, especially when combined with HPV tests, particularly in low-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Collected Samples in Cervical Cancer Screening: Results of HPV and Pap Self-Collected Samples Compared to Physician-Obtained Specimens. Mangold, BR.[2022]

Cytology alone has limited sensitivity for detecting high-grade cervical intraepithelial neoplasia (CIN 2-3), with only 22% sensitivity for high-grade SIL, highlighting the need for additional screening methods like colposcopy.

Colposcopy significantly improves detection rates of CIN, increasing the identification of CIN 2-3 by 32% and CIN 1 by 48%, suggesting that women with atypical cytology results should be referred for colposcopy to ensure accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of atypical and low-grade cervical cytology in private practice. Nyirjesy, I., Billingsley, FS., Forman, MR.[2022]

The AutoCyte PREP liquid-based, thin-layer preparation method for cervical cytology showed better agreement with histologic diagnoses compared to the conventional Pap smear, indicating improved diagnostic accuracy.

This method not only reduced the number of cases classified as atypical squamous cells of undetermined significance but also significantly increased the detection rates of squamous intraepithelial lesions (SILs), suggesting it is more effective in identifying true cases rather than leading to overdiagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biopsy-based comparison of liquid-based, thin-layer preparations to conventional Pap smears. Vassilakos, P., Schwartz, D., de Marval, F., et al.[2022]

A new self-sampling device for collecting cervical cell material showed a high concordance (87%) with traditional gynecologist-collected samples for detecting high-grade cervical intraepithelial neoplasia (CIN), making it a reliable option for cervical screening.

The sensitivity of hrHPV testing from self-obtained samples (92%) was comparable to that of samples taken by gynecologists (95%), suggesting that this user-friendly method could encourage more women to participate in cervical screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. Brink, AA., Meijer, CJ., Wiegerinck, MA., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Triage of women with ASCUS and LSIL on Pap smear reports: management by repeat Pap smear, HPV DNA testing, or colposcopy? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Bethesda system and evaluation of abnormal pap smears. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

World wide web-based cytological analysis of atypical squamous cells cannot exclude high-grade intraepithelial lesions. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Management of atypical squamous cells of undetermined significance and low-grade squamous intra-epithelial lesion by human papillomavirus testing. [2022]

5. Lebanon pubmed.ncbi.nlm.nih.gov

Atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) and histology. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

[Verification of doubtful PAP smear results of women included in the screening program in the Podlaskie province]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Role of Pap Test terminology and age in the detection of carcinoma invasive and carcinoma in situ in medically underserved California women. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Self-Collected Samples in Cervical Cancer Screening: Results of HPV and Pap Self-Collected Samples Compared to Physician-Obtained Specimens. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of atypical and low-grade cervical cytology in private practice. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Biopsy-based comparison of liquid-based, thin-layer preparations to conventional Pap smears. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. [2019]